Comparative Evaluation of Two PRF Formulations on Quality of Life and Healing of Apicomarginal Defects

NCT ID: NCT04396743

Last Updated: 2020-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-11

Study Completion Date

2021-04-11

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Healing of apicomarginal defects using 2 different formulations of PRF i.e PRF -high and PRF-medium will be assessed and compared using 2D and 3D criteria. Also, in vitro evaluation of the PRF formulations and quality of life will be compared between the two groups.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Periapical surgery is a viable treatment option in teeth with persistent apical periodontitis, especially in cases which fail to heal by non surgical treatment. Kim and Kratchman classified periradicular lesions into categories A-F. Lesions A-C are of endodontic origin without any periodontal pockets and vary with respect to the size of periapical radiolucency while D-F are combined endodontic - periodontal origin and are ranked accoding to the magnitude of periodontal breakdown. Type F defects are commonly referred to as apicomarginal defects and have worst prognosis among all. The lower success rate is attributed to the apical migration of junctional epithelium and intrusion of non osteogenic connective tissue into the periapical region.

Recently, autologous platelet concentrates have been used instead of the conventional practice of using GTR barrier membranes for treating apicomarginal defects. Till date no human study has compared platelet formulations; PRF-high ( 2700 rpm for 12minutes) and PRF-medium (1500 rpm for 14minutes) to see any difference in the bony healing and the quality of life between the two groups and no study have assessed bony healing of the periapical defect with periodontal communication with the use of CBCT.

Thus, the aim of the present study is to investigate the effect of 2 different formulations of PRF on quality of life and healing outcome of periapical defects with periodontal communications . Also, in vitro histological and immunohistochemical evaluation and comparison of the clots prepared from different centrifugation protocols will be done .

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Apico Marginal Defects

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Periapical surgery with placement of prf high clots

Patients will undergo periapical surgery and PRF-high clot and membrane will be placed inside the bonycrypt and over the denuded root surface respectively before closure of the flap.

Group Type ACTIVE_COMPARATOR

Periapical surgery with use of prf-high clot and membrane

Intervention Type PROCEDURE

Periapical surgery will be done followed by placement of prf-high clot into the defect and membrane over the defect before closure of the flap.

Periapical surgery with placement of prf medium clots

Patients will undergo periapical surgery and PRF-medium clot and membrane will be placed inside the bonycrypt and over the denuded root surface respectively before closure of the flap.

Group Type ACTIVE_COMPARATOR

Periapical surgery with use of prf-medium clot and membrane

Intervention Type PROCEDURE

Periapical surgery will be done followed by placement of prf-medium clot in the defect and membrane over the defect before closure of the flap.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Periapical surgery with use of prf-high clot and membrane

Periapical surgery will be done followed by placement of prf-high clot into the defect and membrane over the defect before closure of the flap.

Intervention Type PROCEDURE

Periapical surgery with use of prf-medium clot and membrane

Periapical surgery will be done followed by placement of prf-medium clot in the defect and membrane over the defect before closure of the flap.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patients of age 16 years and above.
2. Patients with no general medical contraindications for oral surgical procedures (ASA-I and ASA-II according to the classification of the American Society of Anesthesiologist's.
3. periapical defect with periodontal communication.
4. Periodontal pocket \>6mm with apicomarginal communication confined to buccal aspect of interproximal space or mid buccal aspect of the root.
5. Negative response to vitality test.
6. failed previous root canal treatment with purulent discharge or failed previous surgery or recurrent episode of purulent discharge.

Exclusion Criteria

1. Presence of buccal bone on flap elevation.
2. Unrestorable tooth.
3. fractured /perforated roots.
4. smokers.
5. pregnant females and lactating mothers
Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Postgraduate Institute of Dental Sciences Rohtak

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sanjay Tewari

Rohtak, Haryana, India

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

India

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sanjay Tewari

Role: primary

9416259534

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

vidhiendo

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

PRF+1% MF for Class II Mandibular Furcation Defects
NCT03207698 COMPLETED PHASE2/PHASE3